SOCRA - Society of Clinical Research Associates Institutional Review Board (IRB) Questions and Answers 2 — Questions and Answers
Question 1: What is the minimum IRB membership composition?
- Any number from one department
- At least 5 members with diverse backgrounds, including one non-scientific and one unaffiliated member (Correct answer)
- Only 2 physicians
- No requirements
Correct answer: At least 5 members with diverse backgrounds, including one non-scientific and one unaffiliated member
Per 21 CFR 56.107, at least 5 members with varying backgrounds including non-scientific and unaffiliated members.
Requirements: minimum 5 members, diverse backgrounds (experience, race, gender), at least one scientific member, one non-scientific, one unaffiliated. Cannot consist entirely of one gender or profession.
Question 2: Full board review vs expedited review?
- No difference
- Full board requires quorum with discussion and vote; expedited allows chair to review minimal risk research (Correct answer)
- Expedited is less thorough
- Full board only for Phase III
Correct answer: Full board requires quorum with discussion and vote; expedited allows chair to review minimal risk research
Full board requires a convened meeting with quorum; expedited allows designated member(s) to review minimal risk research.
Full board: majority present including one non-scientific member, discussion, majority vote. Expedited: minor changes or minimal risk research in approved categories. Expedited reviewer cannot disapprove research.
Question 3: What is continuing review and how often?
- Optional
- At least annually, at intervals appropriate to the degree of risk (Correct answer)
- Only at study completion
- Only for studies over 5 years
Correct answer: At least annually, at intervals appropriate to the degree of risk
Per 21 CFR 56.109, continuing review must occur at least annually.
Review must occur annually at minimum, before the approval period expires. Assesses proposed changes, unanticipated problems, withdrawals, complaints, and new information.
Question 4: What must the IRB consider when reviewing a protocol?
- Only budget and timeline
- Protocol, consent, investigator qualifications, recruitment, risk/benefit assessment, and participant protections (Correct answer)
- Only the statistical plan
- Only manufacturer info
Correct answer: Protocol, consent, investigator qualifications, recruitment, risk/benefit assessment, and participant protections
The IRB must review the complete protocol, consent, qualifications, recruitment, risk/benefit, and monitoring plans.
Per 21 CFR 56.111: risk minimization, favorable risk-benefit ratio, equitable selection, adequate consent, data monitoring, and privacy protections. Also reviews the IB, CVs, recruitment materials, and compensation.
Question 5: What are IRB responsibilities for unanticipated problems?
- No responsibility
- Must have procedures for receiving, reviewing reports, and determining appropriate actions (Correct answer)
- Only sponsor handles them
- Only reported to FDA
Correct answer: Must have procedures for receiving, reviewing reports, and determining appropriate actions
Per 21 CFR 56.108, IRBs must have written procedures for receiving and reviewing reports of unanticipated problems.
IRBs must have written procedures for prompt reporting, review reports, assess need for modifications or suspension, and report to institution, FDA, and sponsor when appropriate.
Question 6: Can an IRB suspend or terminate a trial?
- Only FDA can
- Yes, for non-compliance or unexpected serious harm per 21 CFR 56.113 (Correct answer)
- Only the sponsor can
- IRBs can only recommend
Correct answer: Yes, for non-compliance or unexpected serious harm per 21 CFR 56.113
Per 21 CFR 56.113, IRBs can suspend or terminate for non-compliance or unexpected serious harm.
Grounds: non-compliance, unexpected serious harm, serious continuing noncompliance, or research no longer meets criteria. Must provide reasons, report to investigator, institutional officials, and FDA.
SOCRA - Society of Clinical Research Associates Institutional Review Board (IRB) Questions and Answers 2
What is the minimum IRB membership composition?